Evaluation of the effect of pentoxifylline in the treatment of patients with Covid-19 disease admitted to the intensive care unit
Design
A randomized clinical trial with a control group and pararell design of 20 patients
Settings and conduct
This study is performed as a clinical trial in Razi Hospital, Rasht, on critically ill patients with COVID-19 admitted to the intensive care unit. After obtaining the informed consent of the patients or their companions, they will enter the study and will be divided into two groups with a ratio of 1: 1 using the randomization method. The website https://www.sealedenvelope.com will be used for randomization. Participants and health care providers responsible for the patient's health will not be blind. Radiologists, research evaluators, and statisticians will be blind to patients' group therapy. For 14 days, patients will be monitored daily for vital signs, blood tests, chest radiographs, and possible gastrointestinal complications. Finally, the two groups will be compared in terms of treatment effectiveness and possible side effects of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients with a diagnosis of respiratory distress and dyspnea with SPAO2 less than 93% or positive PCR and radiographic test on CT SCANNING or Chest X-Ray admitted to the intensive care unit.
Exclusion criteria: pregnant patients, patients who get under therapy for less than 3 days.
Intervention groups
Treatment group: includes 10 patients who receive the national standard treatment regimen for COVID-19 with pentoxifylline for 14 days.Control group: including 10 patients receiving the standard COVID-19 treatment regimen based on the national protocol for 14 days.
Main outcome variables
Clinical signs of covid-19 disease,recovery rate, possible drug side effects,oxygen saturation percentage.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110425006280N11
Registration date:2021-01-27, 1399/11/08
Registration timing:registered_while_recruiting
Last update:2021-01-27, 1399/11/08
Update count:0
Registration date
2021-01-27, 1399/11/08
Registrant information
Name
Mohammad Haghighi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3211 1319
Email address
mohaghighi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-19, 1399/10/30
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of pentoxifylline effect in treatment of patients with COVID-19, hospitalized in an intensive care unit, A randomized clinical trial
Public title
The effect of pentoxifylline in the treatment of Covid-19 disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a clinical diagnosis of respiratory distress and dyspnea with SPAO2 less than 93% or positive PCR and radiographic test on CT SCANNING or Chest X-Ray admitted to the intensive care unit
Exclusion criteria:
pregnant patients
patients who get under therapy for less than 3 days
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients will be randomly admitted to each of the two treatment groups using the randomization method with a ratio of 1:1.
20 patients with Covid-19 disease will be divided into 2 groups of 10 intervention and control. The intervention group will be named A and the control group will be named B. Random blocking will be such that the patients will be assigned numbers 1 to 20, respectively. Then a table will be considered with 6 rows called blocks and each block with 4 parts and each part will be named A and B. In the next step, the numbers will be placed in each cell in order. After all the numbers are placed in the blocks, the people who had the number in house A will receive the intervention medicine and the people who had the number in house B will be considered as the control group.
The website https://www.sealedenvelope.com will be used for randomization.
Blinding (investigator's opinion)
Single blinded
Blinding description
Each patient's group therapy will be determined only after randomization. Participants and health care providers responsible for patients' health will not go blind and will be informed about group therapy. Radiologists, research evaluators, and statisticians will be blind to patients' group therapy. The Sequentially numbered opaque, sealed envelopes: Envelopes method is used to hide random allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Comeetee of Guilan University of Medical Sciences
Street address
Namjoo Avenue, Deputy department OF Guilan University of Medical Sciences
City
Rasht
Province
Guilan
Postal code
4193713189
Approval date
2021-01-06, 1399/10/17
Ethics committee reference number
IR.GUMS.REC.1399.458
Health conditions studied
1
Description of health condition studied
The effect of pentoxifylline in the treatment of covid-19 disease
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Clinical signs of COVID-19 disease
Timepoint
Daily in the morning visit for 14 days
Method of measurement
Observe, measure and record fever, cough, shortness of breath, olfactory and taste disorders, headache, gastrointestinal symptoms, chills and ...
2
Description
Percentage of oxygen saturation
Timepoint
Daily in the morning visit for 14 days
Method of measurement
Based on measurements with pulse oximetery
Secondary outcomes
1
Description
Patient`s recovery
Timepoint
Daily in the morning visit for 14 days
Method of measurement
No need for supplemental oxygen or mechanical ventilation and ICU discharge
Intervention groups
1
Description
Intervention group: This study is performed in critically ill patients with COVID-19 admitted to Razi Hospital after obtaining informed consent from the patient or their companions.The 10 eligible patients randomly selected will receive the national standard COVID-19 treatment regimen with pentoxifylline. The current standard treatment includes antiviral drug Remdesivir, a dose of 200 milligrams on the first day and then 100 milligrams for 5 days, which can be extended to 10 days depending on the clinical condition. The next drug is ReciGen, which is an interferon beta-1 drug. It is given to the patient at a dose of 44 micrograms subcutaneously for 5 days (every other day). The next drug is dexamethasone, which is a glucocorticoid and is given to the patient at a dose of 8 milligrams per day for 10 days. Heparin at a dose of 5000 units subcutaneous 3 times a day, pantoprazole at a dose of 40 milligrams once a day and vitamin C one gram twice a day will be considered for patients.The dose of pentoxifylline is 400 milligrams, which is determined based on creatinine clearance of the patient as follows: Creatinine clearance above 50 milliliters per minute: three times a day, creatinine clearance 10 to 50 milliliters per minute: twice a day, Creatinine clearance less than 10 milliliters per minute: once daily. The treatment period for patients is 14 days. For 14 days, they will be monitored daily for vital signs, electrolytes, blood sugar, liver tests, kidney tests, blood cells, coagulation factors, LDH, inflammatory factors, chest radiographs, and possible gastrointestinal complications. Finally, the two groups will be compared in terms of treatment effectiveness and possible side effects of treatment.
Category
Treatment - Drugs
2
Description
Control group: 10 patients receive the standard COVID-19 treatment regimen based on national protocol. The current standard treatment includes antiviral drug Remdesivir, a dose of 200 milligrams on the first day and then 100 milligrams for 5 days, which can be extended to 10 days depending on the clinical condition. The next drug is ReciGen, which is an interferon beta-1 drug. It is given to the patient at a dose of 44 micrograms subcutaneously for 5 days (every other day). The next drug is dexamethasone, which is a glucocorticoid and is given to the patient at a dose of 8 milligrams per day for 10 days. Heparin at a dose of 5000 units subcutaneous 3 times a day, pantoprazole at a dose of 40 milligrams once a day and vitamin C one gram twice a day will be considered for patients.For 14 days, patients are monitored daily for vital signs, electrolytes, blood sugar, liver tests, kidney tests, blood cells, coagulation factors, LDH, inflammatory factors, chest radiographs, and possible gastrointestinal complications. Finally, the two groups are compared in terms of treatment effectiveness and possible side effects of treatment.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr Mohammad Haghighi
Street address
Razi Hospital, Sardar Jangal Street, Rasht
City
Rasht
Province
Guilan
Postal code
41448 95655
Phone
+98 13 3355 0028
Email
razi.hospital@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice President of Research Guilan university of medical sciences
Full name of responsible person
Dr Mohammadreza Naghipoor
Street address
Vice Chancellor for research, Shahid Siadati Avenue, Namjoo Street,Rasht
City
Rasht
Province
Guilan
Postal code
6694941446
Phone
+98 13 3333 5821
Email
naghi@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President of Research Guilan university of medical sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Mohammad Haghighi
Position
Full professor of Critical Care Medicine
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Razi Hospital, Sardar Jangal Street, Rasht
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 1322 3970
Fax
+98 13 1323 9842
Email
manesthesist@gmail.com
Web page address
https://isid.research.ac.ir/Mohammad_Haghighi2
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Mohammad Haghighi
Position
Professor of Critical Care Medicine
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Razi Hospital, Sardar Jangal Street, Rasht
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 1322 3970
Fax
+98 13 1323 9842
Email
manesthesist@gmail.com
Web page address
https://isid.research.ac.ir/Mohammad_Haghighi2
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohadese Ahmadi
Position
Research Expert/(MSc) English
Latest degree
Master
Other areas of specialty/work
Expert of Research Affairs
Street address
Anestesiology Reseaech Center, Alzahra Hospital, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 3336 9328
Email
p.ahmadi2311@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available